At Boston Scientific, the business problem is to design world-class Ambulatory Cardiac Monitoring Systems (CDx) while ensuring safety risk engineering activities, including Hazard Analysis, Fault Tree Analysis, and Design Failure Modes and Effects Analysis (DFMEA), are properly conducted to advance science for life and improve patient health.
Requirements
- Experience developing or supporting complex, high-reliability systems in a regulated industry, including medical devices, pharmaceuticals, or aerospace
- Familiarity with risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, DFMEA, and Corrective and Preventive Actions (CAPA)
- Direct experience in risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA
- Experience developing Class II or III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD)
- Experience working with Regulatory Affairs in product submissions
- Strong mechanical, electrical, software, or systems aptitude
- Experience using quality tools and methodologies for design optimization including DFMEA, Design of Experiments (DOE), Brainstorming, Root Cause Analysis, 5 Whys
Responsibilities
- Owns, creates, maintains and/or supports safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, and DFMEA
- Provides support to Design Quality Engineers on new product development and sustaining engineering projects
- Highly cross-functional in nature, this role consults with product experts, R&D, post-market quality, and medical safety functions for risk analysis across the life of Boston Scientific CDx products
- Develops and maintains the CDx risk management best practices including benchmarking with industry leaders, BSC product lines and as a member of the BSC Risk Management CoP
- Lead safety risk engineering activities including Hazard Analysis, Fault Tree Analysis, and Design Failure Modes and Effects Analysis (DFMEA)
- Work with cross functional team to solve complex engineering problems using analysis, experimentation, and statistics
- Familiarity with risk management processes, including Hazard Analysis, Fault Tree Analysis, Risk Management Plan, Risk Management Report, DFMEA, and Corrective and Preventive Actions (CAPA)
Other
- Bachelor’s degree in Electrical Engineering, Software Engineering, Systems Engineering, Mechanical Engineering, Biomedical Engineering, Material Science, or related discipline
- Minimum of 3 years of experience in safety risk engineering, design assurance, post-market quality, or R&D
- Team player with a record of success in a fast-paced, dynamic environment
- Good communication and analytical skills
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time
